tbuckley/cabot-search huggingface dataset:
Randomized controlled phase III trial of weekly paclitaxel ± ofranergene obadenovec (VB-111) for platinum-resistant ovarian cancer (OVAL Study/GOG 3018).
Authors: Rebecca Christian Arend, Bradley J. Monk, Ronnie Shapira-Frommer, Angeles Alvarez Secord, Thomas J. Herzog, Krishnansu Sujata Tewari, Jonathan A. Ledermann, Tamar Rachmilewitz Minei, Marc E. Buyse, Ashley Haggerty, Edwin A Alvarez, Amnon Amit, Carolyn Muller, Antonio Casado Herraez, Laura L. Holman, Joshua Cohen, Marilyn Huang, Adelya Yachnin, Dror Harats, Richard T. Penson
Journal: Journal of Clinical Oncology (2023)

5505 Background: Ofranergene obadenovec (ofra-vec, VB-111) is a nonreplicating adenoviral vector with a murine pro-endothelin 1 (PPE-1-3X) promoter and pro-apoptotic Fas-tumor necrosis factor receptor 1 (TNFR1) chimeric transgene thought to have a dual mechanism of action: vascular disruption and immune activation. Methods: This is a randomized, placebo-controlled, double-blind, multi-center randomized phase III trial (ClinicalTrials.gov identifier: NCT03398655) of ofranergene obadenovec combined with paclitaxel vs paclitaxel with placebo for the treatment of patients with recurrent platinum resistant ovarian cancer (PROC). Patients were randomly assigned 1:1 to receive IV VB-111 1x10 13 viral particles (VPs) every 8 weeks with weekly IV paclitaxel 80 mg/m2 or placebo with paclitaxel until disease progression. The dual primary endpoints were overall survival (OS) and progression free survival (PFS) as assessed by Blinded Independent Central Review (BICR). Results: Between December 2017 and March 2022, 409 patients were randomized at 86 clinical sites in US, Israel, Spain, Poland and Japan. The median PFS was 5.29 months in the VB-111 arm and 5.36 months in the control arm; hazard ratio (HR) 1.03 (CI: 0.83-1.29, p = 0.7823), and median OS with was 13.37 months vs. 13.14 months HR 0.97 (CI: 0.75–1.27 p = 0.8440). Objective response rates (ORR) were similar in both arms: RECIST 1.1 ORR was 28.9% with VB-111 vs. 29.6% with control (CA-125 ORR 41.1% vs 49.4%). In both treatment arms response to CA-125 was a substantial prognostic factor for both PFS and OS. In the VB-111 arm, the HR in CA-125 responders compared to non-responders was for PFS HR 0.2428 (CI: 0.1642-0.3588), and for OS HR 0.3343 (CI: 0.2134-0.5238). Safety profile was consistent with the known safety profile of ofra-vec and was characterized by common transient flu like symptoms such as fever and chills. Conclusions: The addition of ofranergene obadenovec to paclitaxel did not improve PFS or OS. Clinical trial information: NCT03398655 .
Darolutamide and time to pain progression by disease volume in ARASENS.
Authors: Matthew Raymond Smith, Bertrand F. Tombal, Fred Saad, Karim Fizazi, Cora N. Sternberg, E. David Crawford, Jeanny B. Aragon-Ching, Martin Schostak, Ronald Tutrone, Ateesha F. Mohamed, Natasha Littleton, Rui Li, Shankar Srinivasan, Maha H. A. Hussain
Journal: Journal of Clinical Oncology (2023)

e17075 Background: In ARASENS (NCT02799602), darolutamide (DARO) + androgen-deprivation therapy (ADT) + docetaxel significantly reduced risk of death by 32.5% (hazard ratio [HR] 0.68, 95% confidence interval [CI[ 0.57–0.80; P&lt; 0.0001) and significantly delayed time to pain progression (HR 0.79, 95% CI 0.66–0.95; P= 0.006) vs placebo (PBO) + ADT + docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC). We report time to pain progression in patients (pts) with high/low disease volume (HV/LV). Methods: Pts with mHSPC were randomized to oral DARO 600 mg twice daily or PBO, both + ADT + docetaxel. Pain was assessed by the Brief Pain Inventory short form “pain at its worst” score (WPS). Pain progression was defined as WPS increase ≥2 points from nadir (and absolute WPS ≥4 if &gt; 0 at baseline) or initiation of opioid therapy for ≥7 consecutive days. A sensitivity analysis assessed pain progression after completion of docetaxel. HV/LV subgroups were defined per CHAARTED. Results: 1305 pts (DARO 651, PBO 654) were analyzed. At baseline, the mean WPS was 1.5 (standard deviation 1.9) vs 1.4 (1.8) in the DARO vs PBO groups; 258 (40%) vs 274 (42%) pts had no pain (WPS 0). DARO + ADT + docetaxel had a robust impact on delaying time to pain progression vs PBO + ADT + docetaxel in the post-docetaxel sensitivity analysis (stratified HR 0.75, 95% CI 0.62–0.90) and in the HV subgroup (unstratified HR 0.75, 95% CI 0.61–0.93) (Table). Overall, median time to pain progression was longer in the LV vs HV subgroup. WPS change from nadir was the main driver of pain progression events. Conclusions: In pts with mHSPC, the addition of DARO to ADT and docetaxel provided clinically meaningful benefit through delayed time to pain progression, notably in pts with HV disease. Increased overall survival, a delay in time to pain progression, and a favorable safety profile set DARO + ADT + docetaxel as a new standard of care for pts with mHSPC. Clinical trial information: NCT02799602 . [Table: see text]
Preclinical testing of farletuzumab ecteribulin (FZEC [MORAb-202]) and MORAb-109, folate receptor α and mesothelin targeting antibody-drug conjugates (ADCs), in rare gynecologic cancers.
Authors: Cassandra J. Vandenberg, Katherine Rybinski, Ksenija Nesic, Ratana Lim, Chloe Neagle, Gwo-Yaw Ho, Gayanie Ratnayake, Anthony T. Papenfuss, Keiji Furuuchi, Holly E. Barker, Clare L. Scott
Journal: Journal of Clinical Oncology (2023)

e17634 Background: Rare gynecologic cancers, such as ovarian carcinosarcoma (OCS), uterine serous carcinoma (USC) and ovarian clear cell adenocarcinoma (OCCA), have limited treatment options and molecular alterations that drive cell proliferation and drug resistance, resulting in poor overall survival. The anti-microtubule agent (AMA) paclitaxel is used in first-line treatment of most gynecologic cancers; however, the AMA eribulin is known to have additional anticancer properties (Goto et al. Anticancer Res 38:2929, 2018; Ho et al. Cancer Res 82:4457, 2022). Eribulin ADCs have been developed for targeted delivery to limit toxicity and maximize response. FZEC is an anti-folate receptor α (FRA)-eribulin ADC (Shimizu et al. Clin Cancer Res 27:3905, 2021) and MORAb-109 targets eribulin to mesothelin (MSLN; Albone et al. Annals Oncol 31:S491, 2020). Here we provide preclinical data to support clinical trials of FZEC and MORAb-109 in rare gynecologic cancers. Methods: Fresh tumor tissue from patients consented to the WEHI Stafford Fox Rare Cancer Program was used to establish a cohort of patient-derived xenograft (PDX) models of high-grade serous ovarian carcinoma (HGSOC), OCS, USC and OCCA. PDX models were screened for FRA and MSLN expression by IHC and quantified by HALO software, and 15 models were selected for in vivo testing. Tumor-bearing mice were treated with eribulin (1 mg/kg TIW 3 wks), FZEC (12.5 mg/kg Q14Dx3) or MORAb-109 (25 mg/kg Q14Dx3) and compared to standard of care treatments. Results: About 80% of HGSOC PDX models were FRA positive with no difference between models from chemonaïve samples vs multiple lines of prior treatment. FRA expression was frequent in USC and OCCA models, with MSLN seen in a smaller subset. Despite most (80%) models being cisplatin refractory, 11/15 responded to eribulin with the 4 non-responders having high MDR1 expression and being from previously treated patients. Overall, responses to FZEC and MORAb-109 appeared to correlate with FRA and MSLN expression; importantly, some models with moderate to high target antigen expression showed deeper and more durable responses to FZEC and MORAb-109 compared to eribulin. Conclusions: Responses to FZEC and MORAb-109 correlated with FRA and MSLN expression, with equivalent or better activity compared to eribulin in target-positive PDX models of HGSOC, USC and OCCA. [Table: see text]
NALIRIFOX vs FOLFIRINOX vs gemcitabine plus nab-paclitaxel as first-line treatment of advanced pancreatic cancer: An individual patient data pooled analysis of phase 3 registration trials.
Authors: Federico Nichetti, Simone Rota, Eleonora Gusmaroli, Chiara Carlotta Pircher, Andrea Franza, Filippo G. De Braud, Maria Di Bartolomeo, Monica Niger
Journal: Journal of Clinical Oncology (2023)

e16262 Background: The NAPOLI-3 trial showed the superiority of the NALIRIFOX regimen over the combination of gemcitabine and nab-Paclitaxel (GemNabP) as first-line treatment (1LTx) of advanced pancreatic cancer (PDAC), thus being candidate as a reference regimen in this setting. However, a comparison with the FOLFIRINOX regimen has not yet been performed. Methods: We performed a pooled analysis of phase III trials that defined FOLFIRINOX, NALIRIFOX and GemNabP as optimal 1LTx options in advanced PDAC. Individual patient outcomes were retrieved from Kaplan Meier plots of each trial, and analysed after assessment of data reconstruction accuracy. Progression free survival (PFS) and overall survival (OS) were compared between the three different arms, using Cox proportional hazard models including each trial as a random effect variable to account for inter-trial variability. Overall response rates (ORR) and Grade 3 or 4 (G3/4) toxicity rates were also compared. Results: A total of 1372 patients treated with FOLFIRINOX (n=171, 12), NALIRIFOX (n=383, 28) and GemNabP (n=818, 60) were included. Median PFS was significantly longer in patients treated with NALIRIFOX (7.4 months) as compared to FOLFIRINOX [6.4 months, HR 1.48 (95% CI 1.21 - 1.82), p&lt;.001] and GemNabP [5.6 months, HR 1.45 (95% CI 1.24 - 1.70), p = p&lt;.001]. NALIRIFOX also provided significantly higher ORR [42% vs 32% (FOLFIRINOX) vs 29% (GemNabP), p&lt;.001]. GemNabP was associated with poorer OS [9.2 months, HR 1.25 (95% CI 1.07 - 1.46), p=0.005], while no significant difference was observed between FOLFIRINOX [11.1 months, HR 1.12, (95% CI 0.88 - 1.43), p=0.344] and NALIRIFOX (11.1 months). Among G3/4 events, NALIRIFOX was associated with higher rates of diarrhea [p&lt;.001] and lower rates of peripheral neuropathy, thrombocytopenia and neutropenia [p&lt;.001], though with no difference in febrile neutropenia occurrence [p=0.158]. Conclusions: NALIRIFOX may provide superior ORR and PFS as compared to FOLFIRINOX and GemNabP as 1LTx of advanced PDAC, though with higher gastrointestinal toxicities and no difference in OS compared to FOLFIRINOX. Careful patient selection, drug costs consideration and direct comparison between FOLFIRINOX and NALIRIFOX is warranted. [Table: see text]
Peripheral blood epigenetic immune-profiling and survival outcomes with anti-programmed death (PD)-1 based therapy in recurrent/metastatic (R/M) squamous cell carcinoma of head and neck (SCCHN).
Authors: Kartik Sehgal, Ze Zhang, Keisuke Shirai, Rondi Butler, Min Kyung Lee, Annette Molinaro, John Kirk Wiencke, Devin Koestler, Lucas A Salas, Brock C Christensen, Karl Kelsey, Robert I. Haddad
Journal: Journal of Clinical Oncology (2023)

6062 Background: Most patients with R/M SCCHN do not derive durable benefit from standard-of-care anti-PD-1-based therapy. The currently utilized biomarker, PD-ligand-1 combined proportion score is limited by the availability and heterogeneity of tumor samples. There is an unmet need to develop easily accessible peripheral blood-based biomarkers for response to immunotherapy. Methods: We are conducting a prospective multi-center study to identify peripheral blood derived DNA-based methylation biomarkers measured in patients with R/M SCCHN on treatment with FDA-approved anti-PD-1 based therapy. DNA isolated from these samples undergo bisulfite conversion, methylation profiling using Illumina EPIC microarray, and cellular deconvolution to generate peripheral blood immune profiles (PMID 35140201), including granulocytic (g) and monocytic (m) myeloid derived suppressor cell (MDSC) scores. Associations between baseline peripheral blood immune profiles before the start of treatment with progression-free survival (PFS) and overall survival (OS) were evaluated using Kaplan Meier curves and Cox proportional hazards models adjusted for age and sex. Additionally, logistic regression models adjusted for age and sex were utilized to investigate the baseline immune profiles between subgroups of patients who received anti-PD-1 monotherapy with durable clinical benefit for at least 1 year (Group A) versus progression or death within 100 days (Group B) from start of therapy. Results: 61 patients with R/M SCCHN who received anti-PD-1 based therapy as of Oct 31, 2022, were eligible for this preliminary analysis. Mean (SD) age of the entire population was 66.4 (11.8) years, 82% were male. gMDSC score was the only immune parameter with a statistically significant association with PFS (HR 2.6 (1.40 – 4.87) independent of age and sex, with higher scores stratified by median value associated with shorter PFS (Median PFS: 75 days vs. 145 days). Memory CD4 T cells, total CD4 T cells, percentage of T regulatory /CD4 cells, and absolute memory B cells were significantly associated with OS in this population, independent of age and sex (Table). Among the subgroup treated with anti-PD-1 monotherapy, Group A with durable benefit (n = 7, 86% male, mean age: 64.7 years) had significantly higher proportion of CD4 naïve/total CD4 cells (p = 0.03), and significantly lower gMDSC (p = 0.015) &amp; mMDSC (p = 0.000049) scores, compared with Group B (n = 27, 78% male, mean age: 66.4 years). Conclusions: Peripheral blood DNA-based epigenetic immune profiling can recognize clinically relevant methylation biomarkers of benefit from anti-PD-1 therapy before the start of treatment. [Table: see text]
Sequential salvage chemotherapy and lintuzumab-Ac225 results in deep responses and prolonged survival in adverse risk relapsed/refractory AML and in AML patients that received prior venetoclax therapy.
Authors: Sameem M. Abedin, Guru Subramanian Guru Murthy, Avinash Desai, Mary Chen, Ehab L. Atallah
Journal: Journal of Clinical Oncology (2023)

e19030 Background: Lintuzumab-Ac225 is a humanized CD33 antibody conjugated to an alpha emitting isotope, Ac225, delivering high energy radiation to CD33 expressing AML blasts. Preclinical studies indicate Lintuzumab-Ac225 also depletes the anti-apoptotic protein MCL-1, which is a known resistance factor in BCL2-inhibitor (venetoclax (Ven)) exposed patients (pts). We performed a Phase I study where Lintuzumab-Ac225 was administered after salvage chemotherapy, and this study demonstrated safety and encouraging response rates in R/R AML. Herein, we report results of high-risk patients who enrolled to this study. Methods: R/R AML pts deemed fit, and with CD33 expression on &gt;25% of blasts were enrolled onto a Phase I study, Lintuzumab-Ac225 in Combination with Cladribine + Cytarabine + Filgrastim + Mitoxantrone (CLAG-M). Induction consisted of G-CSF, 300mcg/d on D1-6, cladribine 5mg/m2 on D2-6, cytarabine 2g/m2 on D2-6, and mitoxantrone 10mg/m2 on D2-4. Lintuzumab-Ac225 was administered once on D8 ±1 day. The trial enrolled to 4 cohorts, with Lintuzumab-Ac225 at doses ranging from 0.25 uCi/kg to 1.0 uCi/kg. We defined high-risk pts as those who met ELN 2019 criteria for adverse risk disease, or pts who received a Ven combination prior to trial enrollment. Response is descriptively reported, and KM estimator was used to report overall survival (OS). Results: 19 pts on trial met high-risk criteria. Of these, 16 pts had ELN adverse risk disease, a TP53 mutation was detected in 75% (n=12) of pts. Median age was 65 yrs, pts received a median 2 lines of prior therapy, including prior allo-HCT in 58% (n=11), and prior Ven combination in 68% (n=13) of pts. In high-risk pts, 42% (n=8) of pts achieved CRc (CR+CRi), 16% (n=3) achieved MLFS, for an overall response rate (ORR) of 58%. Among evaluable pts achieving CRc, 71% achieved flow MRD negativity. Median OS was 7.4 months. Table reports results in select subgroups. Prior to treatment initiation, 7 pts were deemed eligible for first HCT. 4 (57%) were successfully able to bridge to HCT. Median survival among transplanted pts was 28 months. Post-HCT, one pt died due to GVHD, one due to relapse. Conclusions: CLAG-M in combination with Lintuzumab-Ac225 yielded significantly better clinical outcomes in high-risk populations, particularly in pts previously treated with Ven combinations (median OS 13.8 mo.) and in pts with TP53 mutations (median OS 7.3 mo.), for which recent studies have reported a survival of 4 months or less. The results support further advance in late-stage clinical development of Lintuzumab-Ac225 in combination with CLAG-M in R/R AML, especially in high-risk pts. Clinical trial information: NCT03441048 . [Table: see text]
Survival outcomes of acute erythroid leukemia in the United States: A 20-year population-based study.
Authors: Kriti Gera, Daniela Martir, Wei Xue, John R. Wingard
Journal: Journal of Clinical Oncology (2023)

e19031 Background: Acute Erythroid Leukemia (AEL), also known as pure erythroid leukemia, is a rare subtype of Acute Myeloid Leukemia (AML) characterized by proliferation of malignant erythroid precursors. It can occur at any age and portends aggressive course with dismal outcomes. Treatment consists of high-intensity chemotherapy and allogeneic hematopoietic stem cell transplant. Outcome data at a population level is scarce. Methods: We performed a retrospective analysis of the Surveillance Epidemiology and End Results (SEER) database, a U.S. population-based registry maintained by National Cancer Institute. All cases with histologically confirmed diagnosis of Acute erythroid leukemia during the period of 2000-2019 were included in the study. Survival analysis was performed using Kaplan-Meier method. The survival between groups was compared using log-rank test. Results: A total of 968 patients were included in the study. The median age was 68 years (range 0-95). 62% of patients were males. 11% patients were Hispanic and 89% were non-Hispanic (72% white and 7% black). 62.5% (n=605) patients were treated with chemotherapy. Median Overall Survival (OS) for patients with age &lt;18 years (n=50) was 69 months with 1-year OS of 77%. In contrast, median OS for adults with age &gt;18 years (n=918) was only 5 months with 1-year survival of 26.7%. Patients who received chemotherapy had significantly improved OS compared to patients who did not among both adults (Median OS 8 vs 1 months, p&lt;0.0001) and children (Median OS 152 vs 2 months, p=0.004). There were no significant differences in OS based on sex, race, ethnicity and median household income. Median OS for adults diagnosed in 2000-04, 2005-09, 2010-14, 2015-19 was 4, 6, 6 and 3 months respectively with no significant difference in OS between these groups. Conclusions: AEL occurs in all age groups but is most common in elderly. Outcomes are poor with current chemotherapeutic agents, with no improvement in last two decades. This study stresses the urgent need for new investigational agents and treatment strategies. [Table: see text]
Real world sequence of peptide receptor radionucleotide therapy (PRRT) and chemotherapy in patients with metastatic pancreatic neuroendocrine tumors (pNETs).
Authors: William James Phillips, Elena Tsvetkova, Macyn Leung, Gautham Nair, Stephen Welch, David Laidley, Tim Asmis, Michael M. Vickers, Morgan Black, Robin Sachdeva, Horia Marginean, Rachel Anne Goodwin
Journal: Journal of Clinical Oncology (2023)

e16237 Background: Peptide Receptor Radionuclide Therapy (PRRT) is an effective therapy for advanced pNETs but carries long-term risks of myeloid neoplasia. Early data from United States centres may suggest a higher risk of myelodysplasia and leukemia in patients treated with temozolomide prior to PRRT. The objective of this study is to characterize the sequence of PRRT and chemotherapy at two Canadian pNET treatment centres, distinguished by the availability of PRRT. Methods: This is a multicentre retrospective cohort study involving The Ottawa Hospital Cancer Centre (TOHCC; PRRT non-treatment centre (PRRT-NTC)) and London Regional Cancer Centre (LRCC; PRRT treatment centre (PRRT-TC). Patients with histologically confirmed pNETs between January 2010 – June 2021 over the age 18 (n=226), with metastatic disease (n=177) were included. Demographic, clinical and cancer treatments were collected. Descriptive statistics were used to evaluate the sequence of systemic therapy. Results: 177 patients with metastatic pNET were identified. Systemic therapies included octreotide (n=59, 40%), lanreotide (n=47, 32%), targeted agents (n=40, 27%), chemotherapy (n=48, 33%) and PRRT (n=47, 32%). Of patients receiving chemotherapy, 22 (46%) received temozolomide-containing regimens. The most frequent first line therapies were somatostatin analogues (SSAs, n=76, 43%), chemotherapy (n=23, 13%) and observation (n=18, 10%), second-line were PRRT (n=24, 14%), targeted therapy (n=26, 15%) and SSA (n=13, 7%), and third-line were PRRT (n=15, 9%), chemotherapy (n=11, 6%) and targeted therapy (n=8, 5%). There were 83 (47%) patients treated at the PRRT-TC, of which 33 (40%) received PRRT prior to chemotherapy and 7 (8%) received temozolomide-containing therapy prior to PRRT. In comparison, 94 (53%) patients were treated at the PRRT-NTC, of which 1 (1%) received PRRT prior to chemotherapy and 0 (0%) received PRRT prior to temozolomide-containing therapy. Conclusions: In this large cohort of metastatic pNET patients, the sequence of chemotherapy and PRRT showed centre-to-centre variability with patients treated at a PRRT-TC being more likely to receive chemotherapy, including temozolomide, prior to PRRT. This may be explained in-part by referral/practice patterns, and PRRT availability. These findings suggest an opportunity to evaluate and optimize the sequence of systemic therapy with the increasing availability of PRRT.
The effect of antibiotic (Abx) use on immune checkpoint inhibitor (ICI) efficacy in patients (pts) with metastatic urothelial carcinoma (mUC) in a real-world setting.
Authors: Ubenthira Patgunarajah, Scott Dawsey, Nikhil Pramod, Kimberly Maroli, Moshe Chaim Ornstein, Christopher Eing Wee, Timothy D. Gilligan, Allison Martin, Amanda Nizam, Omar Y. Mian, Wei Wei, C. Marcela Diaz-Montero, Paul G. Pavicic, Jane Nguyen, Shilpa Gupta
Journal: Journal of Clinical Oncology (2023)

4580 Background: Use of Abx may negatively affect outcomes with ICI, possibly due to negative impact on gut microbiota. We previously showed that in our real world cohort of 138 mUC pts, Abx use within 30 or 60 days (d) of ICI initiation did not impact overall survival (OS). We now report updated follow-up (fu) and results from our expanded cohort of 310 mUC pts who received ICI. Methods: We performed a retrospective analysis of adult pts with mUC treated at the Cleveland Clinic between 2015 and 2022 who received 2 or more cycles of ICI with pembrolizumab (P), atezolizumab (A) or avelumab (Av). Effect of Abx use within 30 and 60 (d) of ICI initiation was correlated with progression free survival (PFS) and OS. OS and PFS were estimated using Kaplan-Meier method and compared using log rank test. Results: Median age of pts was 71 years (41-90) and 75% pts were males. 224 pts (72.3%) received P, 82 (26.4%) A and 4 (1.3%) Av. Fluoroquinolones (31.1%), penicillins (29.6%) and cephalosporins (19.7%) were most commonly used Abx. With a median fu of 47 weeks (3.86- 325.3), median OS in pts who received Abx within 60 (d) prior to ICI was 11.79 months (mos) vs 14.55 mos in those who did not receive Abx (p=0.007) and median PFS was 3.68 mos vs 5.29 mos respectively (p=0.038). Median OS in pts who received Abx within 30 days prior ICI was 10.41 mos vs 14.46 mos in those who did not receive Abx (p=0.037). There was a non-significant trend for worse PFS in pts who received Abx within 30 (d) prior to ICI (3.06 mos vs 5.03 mos, p=0.238). There was no effect on OS or PFS with Abx use 30 or 60 (d) after ICI initiation. Conclusions: In our real-world cohort of mUC pts receiving ICI, Abx use 60 and 30 (d)prior to ICI initiation was associated with significant worse OS and worse PFS for the former group but Abx use after ICI initiation did not have an effect on OS or PFS. These findings have the potential to influence clinical practice, including a higher threshold for giving Abx to mUC pts starting ICI. Further prospective studies are warranted. [Table: see text]